A Safety Profile You Can Rely On

Periodic laboratory results showed no clinically significant changes in:

• Blood chemistry
• Hematology
• Urinary protein
• Urinary glucose
• Urinary hemoglobin
• Thyroxine**
• Luteinizing hormone
• Follicle stimulating hormone
• GH antibodies
• Thyroid stimulating hormone (TSH)

Increases occurred in alkaline phosphatase and serum phosphorous levels.

There were no unexpected changes in:

• Serum somatomedin-C (IGF-1)
• Tanner maturation scores

TEV-TROPIN^® stimulates linear growth in children lacking endogenous growth hormone (GH). Treatment of growth hormone deficiency (GHD) children produces growth rate and IGF-1 levels similar to those seen after treatment with hGH of pituitary origin.

GH may be used for long-term treatment in patients with confirmed Prader-Willi Syndrome (PWS) only when diagnosed with GHD. Because of reported fatalities, patients with PWS who are severely obese, have severe respiratory impairment, unidentified respiratory infections, or sleep apnea should not use GH.

Patients should be observed for evidence of glucose intolerance, hypothyroidism, and slipped capital femoral epiphysis. Benzyl alcohol associated with toxicity in newborns is contained in the diluent. Treatment of patients with coexisting ACTH deficiency should have glucocorticoid replacement dose adjusted to avoid inhibition of growth. The safety of using GH in patients with acute critical illness as a complication of open heart or abdominal surgery, multiple accidental trauma, acute respiratory failure, evidence of a progressive underlying intracranial lesion, or closed epiphysis has not been established.

In studies of GH-deficient children, headaches occurred infrequently. Injection-site reactions (e.g., pain, bruise) occurred in 8 of the 164 treated patients.

**Below lower limit of normal was detected. No patients were hypothyroid.

Growth Solutions^SM is a service mark of TEVA Pharmaceuticals USA.
TEV-TROPIN^® is a registered trademark of TEVA Pharmaceuticals USA.